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Merck, a drug company, is trying for the third time to get approval from the Food and Drug Administration (FDA) to allow Mevacor® to be sold over the counter. Mevacor®, generically known as lovastatin, is commonly prescribed by doctors and sold as a prescription product. This drug is part of a class of medications called "statins" which all lower cholesterol in a similar way. The over the counter version would only be available in one strength, to decrease the amount of adverse events.
Promoters of this medication going over the counter say that people will get the benefits of lower cholesterol that otherwise would not, because they either don't want to go to the doctor or can't afford to. This would therefore decrease the patients' cardiovascular risks such as: heart attacks, strokes, or peripheral arterial disease thereby increasing their overall health.
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As mentioned earlier this is Merck's third attempt at getting this approved, meaning there have been two denials from the FDA. Most medications that are over the counter provide symptomatic relief to some type of ailment. There is a definite reason why the patient is taking the medication and the patient knows the medication is working because their symptoms go away. High cholesterol, on the other hand, has no symptoms. Without a cholesterol level from the doctor, the patient wouldn't know that they had a problem. If the patient takes the medication they will have no clue whether the medication is being effective without a blood test. Not only do cholesterol levels need to be taken for effectiveness but liver function tests need to be monitored because this drug may cause liver damage. This is a rare side effect, but this needs to be monitored none the less.
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One other downside to having this agent over the counter is that this gives another reason to avoid the doctor. The patient population that has high cholesterol is at higher risk for high blood pressure, diabetes, and heart disease. These patients need to be taken care of by a primary physician to get the care that they need.
For more information regarding this or other medications for high cholesterol, or cholesterol in general contact your doctor or pharmacist.
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